1. Alternative technologies: performance and regulatory status Mexico City, Mexico July 2019

2. Title

3. Most viral load labs are in major urban centre
Kenya
Zimbabwe
Uganda
Malawi
These data are being updated, but primarily viral load labs are generally located in urban centres. The green circles represent the 6-24 hour radius around the labs within which blood samples can be transported to the lab. Generally, blood samples beyond this radius should not be tested, but alternative sample types or technologies considered unless infrastructure improves considerably.
Note: this slide only reflects the PCR testing labs used for VL testing in the public sector. This excludes private PCR testing labs or those used for research purposes. Some circle represent multiple labs in the same city

4. … and so are the largest ART facilities where patients seek care
52% [38% - 90%] of ART patients1 are at facilities close to centralized labs and can transport samples within 24 hours
Can be accessed using EDTA blood
Fortunately, a significant proportion (48%) of ART patients seek care within 24 hours of these labs. Again, these data are being updated. However, this also indicates that in order to expand access to viral load, half of patients cannot be tested using the gold standard of plasma in the laboratory. So alternative strategies, such as dried blood spots, point-of-care, etc will need to be considered.
Require alternative strategy
1 Data based on facility level ART patient numbers Eswatini, Nigeria, Rwanda, and Zimbabwe

5. How quickly do we need to get samples to the lab?
24 hours
8 hours
6 hours
Abbott
Hologic
Roche
Cepheid
Cavidi
Siemens

6. So how do we provide greater access to viral load testing?
Plasma
Dried blood spots
Dried plasma spots
Plasma preparation tubes
Near POC
VL for EID

7. An increasing menu of options exists
WHO prequalification:
Abbott RealTime m2000
Abbott m-PIMA
bioMerieux EasyQ
Cepheid Xpert
Hologic Aptima
Roche COBAS v2.0
Siemens VERSANT

8. Dried blood spot specimens

9. Dried plasma spot specimens
Very similar to dried blood spot specimens, except spot the filter card with plasma
Requires a centrifuge at the location of spotting, either health care facility or a hub

10. Plasma preparation tubes

11. Near point-of-care viral load technologies
For consideration in 2020 Consolidated Guidelines revision

12. What is the impact of POC VL?
There is currently no WHO recommendation to use point-of-care or near point-of-care technologies for treatment monitoring; however, impact studies and implementation considerations are ongoing.
POC VL
Pregnant women
Infants and children
Advanced disease
Suspected failing
Re-entering care
Currently we don’t yet recommend POC VL; however, impact studies and implementation considerations are ongoing. This question will, therefore, be considered and reviewed in 2020 guideline processes, both for the general population as well as for some of these potential sub-populations.

13. Call for diagnostic integration
Several calls for diagnostic integration using these multiplex technologies have been raised, including from WHO with an information note released in 2016 (on left). Further, Unitaid also developed a landscape document highlighting several of these technologies (right doc).
Additionally, a meeting will be held here in Geneva co-hosted by ASLM and WHO HIV and TB departments in July with about 20 countries from all regions to discuss best practices and challenges of diagnostic integration.
As of 31 December 2018, a total of 10,562 GeneXpert instruments (comprising 47,567 modules) had been cumulatively procured in the public sector in 136 of the 145 countries eligible for concessional pricing.
Additional guidance to be developed in 2019 and 2020

14. Plasma preparation tubes
Conclusions
Plasma
Dried blood spots
Dried plasma spots
Plasma preparation tubes
Near POC
VL for EID
We have a number of technologies and specimens at our disposal, with regulatory approvals, that can support expansion of viral load scale-up
Re-focus our diagnostic thinking on how best to implement these strategies / interventions and improving the clinical-lab interface, ensuring results are being used
Let’s get viral load results into the hands of the clinicians and all recipients of care!

15. Acknowledgements Robert Luo, Kameko Nichols and Neil Parkin
ASLM: Charles Kiyaga and Anafi Mataka
CHAI: Paolo Maggiore, Maria Rosezoil Rioja and Jilian Sacks
EGPAF: Jennifer Cohn
USAID: Dianna Edgil, Matthew Wattleworth and Jason Williams
WHO: Fatim Cham Jallow, Fausta Mosha, Mercedes Perez and Ute Stroher
Link: